Real Time PCR Solutions for Food Safety

Data Integrity Master Class - Vienna Austria

2018, June 6 - 8

Pharmaceutical » Seminar

Data Integrity is one of the basic GMP principles. Multiple Data Integrity citations were reported by FDA and European inspectors during the last 3 years. Many US Warning Letters and EU Non-Compliance Reports deal with serious Data Integrity violations. Data Integrity questions have been, and will, continue be the focus of many GMP inspections.

As a consequence international authorities – FDA, EMA, PIC/S, WHO, MHRA - published draft documents to describe the regulatory expectations of Data Integrity.
Although all guidelines are not intended to impose an additional regulatory burden to the regulated companies, a lot of uncertainty predominates the pharmaceutical industry as to how to implement these requirements into the daily business.

For information visit





Concept Heidelberg
Phone: +[49] 62 21/84 44 0
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